On April 21, 2020, the Regulation on the Requirements and Reimbursement Process for Digital Health Applications (Digitale Gesundheitsanwendungen-Verordnung or „DiGAV“, available here) entered into force in Germany.  Among other provisions, the DiGAV includes specific IT security and privacy requirements.  Shortly after the law took effect, Germany’s Federal Medicines and Medical Devices Agency (“BfArM”) also released an extensive explanatory Guidance (Leitfaden, available here) to the DiGAV.

Independently, on April 15, 2020, the German Federal Office for IT Security (“BSI”) published a draft version of its guidance on “Security Requirements for Digital Health Applications” (BSI TR-03161) (available here).  The BSI is now seeking feedback from industry on this draft guidance before releasing a final version.

While the scope of application of the DiGAV and the BSI draft guidance may be limited, the documents can serve to provide useful insights and benchmarks for health applications generally.


Continue Reading German Federal Agencies Publish Privacy and IT Security Requirements for Digital Health Applications

On 19 February 2020, the European Commission presented its long-awaited strategies for data and AI.  These follow Commission President Ursula von der Leyen’s commitment upon taking office to put forward legislative proposals for a “coordinated European approach to the human and ethical implications of AI” within the new Commission’s first 100 days.  Although the papers published this week do not set out a comprehensive EU legal framework for AI, they do give a clear indication of the Commission’s key priorities and anticipated next steps.

The Commission strategies are set out in four separate papers—two on AI, and one each on Europe’s digital future and the data economy.  Read together, it is clear that the Commission seeks to position the EU as a digital leader, both in terms of trustworthy AI and the wider data economy.


Continue Reading European Commission Presents Strategies for Data and AI (Part 1 of 4)

On March 29, 2019, the ICO opened the beta phase of the “regulatory sandbox” scheme (the “Sandbox”), which is a new service designed to support organizations that are developing innovative and beneficial projects that use personal data.  The application process for participating in the Sandbox is now open, and applications must be submitted to the ICO by noon on Friday May 24, 2019. The ICO has published on its website a Guide to the Sandbox, which explains the scheme in detail.

The purpose of the Sandbox is to support organizations that are developing innovative products and services using personal data and develop a shared understanding of what compliance looks like in particular innovative areas.  Organizations participating in the Sandbox are likely to benefit from having the opportunity to liaise directly with the regulator on innovative projects with complex data protection issues.  The Sandbox will also be an opportunity for market leaders in innovative technologies to influence the ICO’s approach to certain use cases with challenging aspects of data protection compliance or where there is uncertainty about what compliance looks like.

The beta phase of the Sandbox is planned to run from July 2019 to September 2020.  Around 10 organizations from private, public and third sectors will be selected to participate.  In the beta phase, the ICO is focusing on data processing that falls within the remit of UK data protection law.  
Continue Reading ICO opens beta phase of privacy “regulatory sandbox”

Earlier this month, the UK Government published a consultation on plans to implement the EU Directive on security of network and information systems (the “NIS Directive”, otherwise known as the Cybersecurity Directive).  The consultation includes a proposal to fine firms that fail to implement “appropriate and proportionate security measures” up to EUR 20 million or 4% of global turnover (whichever is greater).

We summarise the UK Government’s plans below, including which organisations may be in scope — for example, in the energy, transport and other sectors, as well as online marketplaces, online search engines, and cloud computing service providers — and the proposed security and incident reporting obligations.

Organisations that are interested in responding to the consultation have until September 30, 2017 to do so.  The UK Government will issue a formal response within 10 weeks of this closing date, and publish further security guidance later this year and next.  A further consultation on incident reporting for digital service providers will be run later this year; the Government invites organisations that are interested in taking part to provide appropriate contact details.
Continue Reading UK Government Proposes Cybersecurity Law with Serious Fines

In a new post on the Covington Digital Health blog, our colleagues discuss a new European Cloud in Health Advisory Council whitepaper calling for a review of European healthcare data protection rules holding back greater adoption of cloud computing and AI; and for more discussion about the ethics and governance of re-use of patient

The EU-U.S. Privacy Shield’s recent introduction has created an efficient mechanism to ensure that trans-Atlantic personal data flows are lawful.  With that in place, attention is now turning back to restrictions within the EU, particularly around hosting data in cloud computing services.

European healthcare is particularly affected by such restrictions.  This has motivated a significant group of organizations and policymakers to come together and launch a collective “call to action” to European policymakers, urging greater support and reforms to enable broader use of cloud computing in healthcare.  The Call to Action was previewed at eHealth Week 2016 in June.
Continue Reading EU Organizations Call for More Support for Cloud Computing in Healthcare

The EU Network and Information Security (NIS) Directive now looks likely to enter into force in August of this year.  Member States will then have 21 months to implement it into national law before the new security and incident notification obligations will start to apply to the following entities:

  • designated* “operators of essential services” within the energy, transport, banking, financial market infrastructures, health, drinking water supply and distribution, and digital infrastructure sectors; and
  • certain “digital service providers” that offer services within the EU, namely online market places, online search engines and cloud computing services, excluding small/micro enterprises.

* Once implemented in national law, Member States will have a further 6 months to apply criteria laid down in the Directive to identify specific operators of essential services covered by national rules; they do not need to undertake this exercise in relation to digital service providers, which shall be deemed to be under the jurisdiction of the Member State in which it has its “main establishment” (i.e., its head office in the Union).
Continue Reading EU Cyber Security Directive To Enter Into Force In August

On April 27, the House of Representative unanimously passed the Email Privacy Act.  As previously reported, the proposed changes would strengthen the privacy protections for email and other cloud-storage services by closing a loophole that allowed law enforcement to access older data without obtaining a warrant.

However, while there is widespread support to require

By Kristof Van Quathem

Yesterday, the European Commission launched its “Digitising European Industry” package, a series of industry related initiatives aimed at “updating Europe’s digital infrastructure”, see press release here, Q&A here and homepage here.  The package includes reports and proposals addressing cloud computing, ICT standardization, eGovernment, Internet of Things (“IoT”), quantum technologies and high performance computing / big data.

Below we summarize the data protection aspects of the key communications published yesterday.
Continue Reading Digital Single Market – New Initiatives for Cloud Computing and Internet of Things